Granufink® simple forte

I N S T R U C T I O N for medical use of the medicinal product GRANUFINK® ProstaForte

Composition:

Active ingredient: 1 capsule contains: dry native extract of pumpkin seed (Cucurbita pepo L. convar. citrullina I. Greb. var. styriaca I. Greb) (15–25 : 1) (extraction solvent – ethanol 92% m/m) – 500 mg;

Excipients: colloidal anhydrous silicon dioxide;

capsule shell: gelatin, black iron oxide (E 172), red iron oxide (E 172), yellow iron oxide (E 172), purified water.

Dosage form. Hard capsules.

Main physicochemical properties: hard gelatin capsules of brown color, size 0.

Pharmacotherapeutic group. Agents used in benign prostatic hyperplasia. ATC code G04C.

Pharmacological properties.

Pharmacodynamics.

GRANUFINC® Prosta Forte contains a concentrated ethanolic extract of pumpkin seeds. The seeds of specially cultivated varieties of medicinal pumpkin C. pepo L. convar. citrullina I. Greb. var. styriaca I. Greb contain a fatty plant oil with specific non-ubiquinone phytosterols (delta-7-sterols) that provide the oil's activity, as well as a large amount of amino acids (arginine, linoleic and oleic acids) which participate in the regulation of bladder function as direct and indirect neurotransmitters. Collectively, phytosterols and amino acids provide urodynamic and anti-inflammatory effects by establishing a balance between contraction and relaxation of the muscles responsible for urination, promoting relaxation of the urinary bladder sphincter, reducing pressure in the urinary bladder, increasing its tone, and reducing swelling.

GRANUFINC® Prosta Forte has demonstrated efficacy and good tolerability in clinical studies in men with symptoms of lower urinary tract disorders due to benign prostatic hyperplasia, alleviating urinary symptoms such as pain, burning, straining or squeezing during urination, and frequent urination during the day and at night.

GRANUFINC® Prosta Forte is considered a traditional herbal medicinal product for use according to specified indications.

Pharmacokinetics.

Not studied.

Clinical characteristics.

Indications.

For relief of symptoms occurring in the lower urinary tract of men due to overactive bladder or benign prostatic hyperplasia, such as urgent need to urinate, frequent urination during the day and at night, incomplete bladder emptying, and straining during urination.

Contraindications.

Hypersensitivity to the active ingredients of this medicinal product or to plants of the Cucurbitaceae family (e.g., watermelon, zucchini, etc.); cholelithiasis (gallstones), hepatitis, pancreatitis.

Special precautions.

This medicinal product reduces discomfort caused by an enlarged prostate gland without reducing its size; therefore, the patient should regularly visit a physician.

You should consult your doctor if, during treatment with this medicinal product:

• your symptoms worsen,
• you develop fever,
• you experience pain during urination,
• you develop urinary retention.

Interaction with other medicinal products and other forms of interaction.

Studies on interactions with other medicinal products have not been conducted.

Cases of interactions with other medicinal products have not been reported.

Usage instructions.

Use during pregnancy or breastfeeding.

GRANUFINC® Prosta Forte is not intended for use in women.

Ability to affect reaction speed when driving vehicles or operating machinery. The drug does not affect the ability to drive vehicles or operate machinery.

Method of Administration and Dosage.

Adults, including elderly patients: 1 capsule twice daily, taken with sufficient liquid, preferably before meals.

Prolonged use is possible. The duration of treatment is determined by a physician.

If you forget to take GRANUFINC® Prosta Forte on time, do not take a double dose instead of the missed dose. Take the next dose as usual, at the time specified by your doctor or indicated in the instructions for medical use.

If you have additional questions regarding the use of this medicinal product, consult your doctor.

Children. Clinical studies on the use of the medicinal product in children (under 18 years of age) have not been conducted; therefore, its use is not recommended in this age group of patients.

Overdose. Cases of overdose have not been reported.

In case of accidental exceeding of the recommended dose of GRANUFINC® Prosta Forte, an increase in adverse reactions is possible.

Adverse reactions.

Not established.

In exceptional cases, moderate gastrointestinal disturbances may occur in individuals hypersensitive to any component of the drug.

The patient should inform the physician about the occurrence of gastrointestinal symptoms so that the physician can assess their severity and the need for treatment.

If any other adverse reactions occur, the patient must consult a physician.

Shelf life. 3 years.

Storage conditions.

Keep out of reach of children.

The medicinal product does not require special storage conditions.

Do not use this medicinal product after the expiry date stated on the blister and cardboard packaging. The expiry date refers to the last day of the month.

Do not dispose of any medicinal products via wastewater or household waste. Ask your pharmacist about how to dispose of medicines no longer in use.

Packaging. 10 capsules in a blister; 2 or 4, or 8, or 14 blisters in a cardboard box. 20 capsules in a blister with a perforation line; 2 or 4, or 7 blisters in a cardboard box.

Availability category. Over-the-counter.

Manufacturer. Omega Pharma Manufacturing GmbH & Co. KG /
Omega Pharma Manufacturing GmbH & Co. KG

Manufacturer's address.
Benzstrasse 25, 71083 Herrenberg, Germany / Benzstrasse 25, 71083 Herrenberg, Germany.